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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bronchoscope (flexible or rigid)
510(k) Number K870063
Device Name CO2 LASER BRONCHOSCOPE SET
Applicant
TTI MEDICAL
3470 MT. DIABLO BLVD.
SUITE A 150
LAFAYETTE,  CA  94549
Applicant Contact ALLEN R HOWES
Correspondent
TTI MEDICAL
3470 MT. DIABLO BLVD.
SUITE A 150
LAFAYETTE,  CA  94549
Correspondent Contact ALLEN R HOWES
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received01/07/1987
Decision Date 03/09/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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